Advanced or recurrent gastric cancer
Conditions
Interventions
Sponsors
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven unresectable or recurrent gastric cancer. 2) ECOG Performance status:0-2 3) Up to one prior chemotherapy 4) 4 weeks rest after prior chemotherapy 5) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST) 6) Adequate organ functions: i) hemoglobin >=9.0g/dL, ii) WBC >=4000/mm3, iii) neutrophils >=2000/mm3, iv) platelets >=100,000/mm3, v) AST(GOT)/ALT(GPT) <=2.5 X UL, vi) total bilirubin <=1.5mg/dL, vii) creatinine <=1.5mg/dL, 7) Life expectancy of more than 3 months 8) Age greater than 20 9) Informed consent approved by IRB
Exclusion criteria
Exclusion criteria: 1) Drug hypersensitivity. 2) Infection and inflammation. 3) Prior infusion of paclitaxel 4) Peripheral neuropathy 5) Active synchronous malignancy. 6) Brain metastasis. 7) Severe mental disorders. 8) Symptomatic pulmonary fibrosis or interstitial pneumonia. 9) Severe systemic edema. 10) A large amount of pleural effusion or peritoneal fluid. 11) Severe heart disease. 12) Myocardial infarction within six months. 13) DM with insulin injection. 14) Pregnant patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS), Progression-free survival(PFS), Time to Treatment Failure(TTF), Adverse Effect | — |
Countries
Japan
Contacts
Public ContactShigefumi Yoshino
Yamaguchi University Graduate School of Medicine Department of Digestive Surgery and Surgical Oncology
Outcome results
None listed